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Maternal Abdominal Morphology Assessment

ConditionsPregnancy RelatedInfant DevelopmentPancreasDiabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-54
SponsorUniversity of Texas at Austin

About this trial

Previous studies have shown that pancreas size tends to be smaller in individuals with diabetes compared to those without diabetes. The investigators have recently found that pancreas size increases during pregnancy. The MAMA study aims to examine changes in the pancreas that occur during pregnancy, in both pregnant mothers and their babies, and find out how they are affected by maternal diabetes.

The MAMA study is a prospective cohort study that will follow women and their babies through pregnancy and one year postpartum. Women aged 18-54, who are under 14 weeks pregnant are being recruited to participate in the MAMA study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant women, with a singleton gestation

Age 18 - 54 years at screening

Gestational age < 14 weeks

Willing to commit to 1 year postpartum follow up

Disqualifiers

Presence of any mechanically or magnetically activated implants

Claustrophobia

Other contraindication for MRI

BMI ≥ 38.0 or maximum width less than 48 cm (necessary to fit within the MRI field of view)

Trial population

The investigators intend to enroll 87 total participants. The study population will consist of women who are under 14 weeks pregnant with a singleton gestation, aged 18-54, living in the Greater Austin Area.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    Observational study

Treatment groups

87 Participants
are divided into 1 treatment group
Group A: MAMA Study Participants1 intervention

Trial outcomes

Primary outcomes

1

Maternal Pancreatic Volume

Maternal pancreatic volume will be measured at each study visit. MRI will be utilized to determine maternal pancreatic volume in cm\^3.

Time frame
15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation as well as 1 year-1 year and 2 months postpartum.
2

Fetal Pancreatic Volume

Fetal pancreatic volume will be measured at each study visit. MRI will be utilized to determine fetal pancreatic volume in utero in cm\^3. Fetal pancreatic volume will not be ascertained at the final study visit.

Time frame
15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation.

Secondary outcomes

1

Plasma Insulin

Plasma Insulin values (µU/mL or pmol/L) measured via blood draw will be utilized to calculate Glycemic Control and Insulin Sensitivity.

Time frame
15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation as well as 1 year-1 year and 2 months postpartum.
2

Plasma Glucose

Plasma Insulin values (mg/dL or mmol/L) measured via blood draw will be utilized to calculate Glycemic Control and Insulin Sensitivity.

Time frame
15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation as well as 1 year-1 year and 2 months postpartum.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas at Austin

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov
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